Cervical intraepithelial neoplasia
Conditions
Sponsors
Hirotake Murakami
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Female patients who are at least 18 years of age at the time consent is obtained 2. Patients diagnosed with CIN2 or CIN3 as a result of sub-colposcopic targeted histology (sub-colposcopic targeted histology) (specimen from the performing facility or specimen from a facility prior to referral that confirmed the lesion) 3.Patients with a PS (Performance status) [ECOG (Eastern cooperation oncology group)] of 0 or 1 4. Patients whose screening test results meet all of the following criteria and whose major organs are sufficiently functional 1) White blood cell count: >3,000/mm3 2) Platelet count: >-100,000/mm3 3) AST, ALT: less than twice the upper limit of the facility standard value 4)Total bilirubin: 2.0 mg/dL or less 5) BUN, serum creatinine: 1.5 times or less than the upper limit of the institutional reference value 5. Patients who have given written consent to participate in the study
Exclusion criteria
Exclusion criteria: 1) Patients with adenodysplasia, intraepithelial adenocarcinoma, squamous cell carcinoma or other cervical malignancy. 2) Patients with UCF (Unsatisfactory colposcopic findings) or TZ type 3 with deep cervical lesions by colposcopy 3) Patients with multiple cancers 4) Patients with poorly controlled cardiac, respiratory, hepatic, renal, gastrointestinal, hematologic, endocrine, neurological or psychiatric diseases 5) Patients with pre-existing or concomitant photosensitivity 6) Patients with porphyria 7) Patients who have undergone PDT using talaporphine sodium or porphymer sodium in the past 8) Pregnant or possibly pregnant women, lactating women, and female patients who wish to become pregnant by the end of the observation period of this study (maximum 24 weeks after PDT) 9) Patients who are unable to use an appropriate contraceptive method (condom, pessary, etc.) or who cannot obtain consent for appropriate contraception from the time consent is obtained until the completion of the observation period of this study (24 weeks after the maximum PDT) 10) Patients who are currently participating in another clinical trial or who have not completed at least 3 months of participation 11) Other patients who are judged by the principal investigator or subinvestigator to be inappropriate as subjects for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in vaginal bacterial cultures before and after photodynamic therapy (PDT) with ME2906 and PNL6405CIN in patients with cervical intraepithelial tumors | — |
Secondary
| Measure | Time frame |
|---|---|
| Final judgment of treatment response: CR (complete response) rate (complete response rate) HR HPV (High risk human papillomavirus) negative result rate Evaluation of treatment response by conical resection after CR (only for patients who have given consent) Incidence of adverse events and diseases Incidence of adverse events, diseases, etc. | — |
Contacts
Public ContactHirotake Murakami
Hamamatsu University Hospital
Outcome results
None listed